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Ministry Of Health Recalls Mislabeled Drug

Ministry Of Health Recalls Mislabeled Drug
September 27
10:43 2019

Friday, Sept. 27th. 2019 –

A batch of injection, which was found to be fraudulently labelled, was rejected and removed from the Western Regional Hospital where it had reportedly been dispatched for distribution before it was inspected and approved by the Drug Inspectorate of the Ministry of Health.

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The Reporter learned that the Diclofenac injection, a drug administered for pain, was relabeled to indicate it was in a presentation that could have been administered in either of two ways – in the vein or the muscle – when its original label had indicated that it should be administered only in the muscle.

Intramuscular injections are prepared to be administered into the muscles, so if they are injected into the veins instead, they can cause damage to a patient’s blood cells. And this could have created a heap of problems at whichever hospital or clinic the importer had the injection dispatched to prior to getting the Ministry’s approval.

But Director of Health Service, Dr. Marvin Manzanero explained to the Reporter on Thursday that the importer, which he described as one of the most compliant pharmaceutical importers, claimed to have a permit with a signed letter from Colombia regarding the injection’s IV use. That letter was sent to him, he said, but they rejected it and instructed that the medication be pulled.

The batch of injection was detected at the Western Regional Hospital and was dispatched to other medical facilities but Manzanero said that “no one is authorized to use it until we give the green light.” He said that the drug inspectorate unit flagged the batch of drugs and recommended that it be recalled. The Ministry has since recalled the injection and sent it back to Colombia.

Manzanero informed that distributors have dispatched drugs to health regions before they are approved for use when those regions request the drugs based on the demand for it. This was the case at the Western Regional Hospital, he explained. But he added that whichever health facility uses medication without the drug inspectorate’s approval, that health facility “would have assumed that responsibility.” He did not say if any action will be taken against the importer for relabeling the medication.

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